Organ Dysfunction Associated With Intra Abdominal Pressures in Liver Transplantation

NCT04463745 | Unknown

• 1 other identifier: ILBS - Liver Transplant-3
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with end stage liver disease have varying degrees of intra-abdominal hypertension (IAH) due to the presence of ascites. The perioperative events may either relieve or aggravate the intra-abdominal pressures. Intra-abdominal hypertension has damaging effect on various organ systems. There is an increase in intracranial pressures and a decrease in cerebral perfusion pressures associated with IAH . In the heart, there is an increase of right atrial pressures, increase in systemic vascular resistance and decrease in cardiac output . Pulmonary complications include increase in the peak, mean and plateau airway pressures, with decreased compliance . Renal dysfunction is an early effect of raised intra-abdominal pressure, resulting from decreased renal blood flow, shunting of blood to the medulla, mechanical compression of the kidneys and increased pressures in the renal veins . We would study the intra-abdominal pressures in liver transplant recipients and record hemodynamic, respiratory, cardiac and renal function prospectively. Follow up data for 6 days for neurological, respiratory, cardiac and renal complications will be collected, along with hospital stay, ICU stay and mortality. The association between intra-abdominal pressures and these outcomes will be analysed.

Conditions

Liver Diseases; Intra-Abdominal Hypertension; Cirrhosis, Liver; Organ Dysfunction Syndrome

Keywords

organ dysfunction; intra-abdominal pressure; liver transplantation; liver cirrhosis

Outcome Measures

Primary Outcomes (2)

• 28 day mortality

  mortality of any cause in the fist 28 days after transplantation

  28 days

• duration of icu stay

  time period spent in the intensive care unit

  28 days

Secondary Outcomes (3)

• Acute kidney injury in 1st week

  7 days

• Respiratory complications

  7 days

• major neurological complications

  7 days

Study Arms (1)

Liver Transplant Recipients

adult patients undergoing liver transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients undergoing liver transplantation for various indications , including chronic liver disease due to alcohol, NASH , viral hepatitis among others.

You may qualify if:

• patients undergoing liver transplantation
• to 65 years

You may not qualify if:

• pregnant patients
• primary diagnosis of Acute liver failure and acute on chronic liver failure

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Liver Diseases; Intra-Abdominal Hypertension; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Digestive System Diseases; Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karthik Ponnappan

  Institute of Liver and Biliary Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karthik Ponnappan

CONTACT

+919840163951; kdtkp@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 9, 2020
• Study Start: July 15, 2020
• Primary Completion: June 15, 2021
• Study Completion: June 30, 2021
• Last Updated: February 4, 2021

Record last verified: 2020-09

Locations

IN (1)